Impact of pharmacometrics on drug approval and labeling decisions: a survey of 42 new drug applications. - Wikidata - wikimedia - TriplyDB

Impact of pharmacometrics on drug approval and labeling decisions: a survey of 42 new drug applications.

Impact of pharmacometrics on drug approval and labeling decisions: a survey of 42 new drug applications.

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The promises of quantitative systems pharmacology modelling for drug development White paper: landscape on technical and conceptual requirements and competence framework in drug/disease modeling and simulation.Quantitative pharmacology approach in Alzheimer's disease: efficacy modeling of early clinical data to predict clinical outcome of tesofensine.Pharmacometrics-based dose selection of levofloxacin as a treatment for postexposure inhalational anthrax in children Response-guided telaprevir therapy in prior relapsers? The role of bridging data from treatment-naïve and experienced subjects.Concepts and challenges in quantitative pharmacology and model-based drug development.Bayesian quantitative disease-drug-trial models for Parkinson's disease to guide early drug development.Overview of model-building strategies in population PK/PD analyses: 2002-2004 literature survey.Exposure-response analysis reveals that clinically important toxicity difference can exist between bioequivalent carbamazepine tablets.Strategies to assess the drug interaction potential in translational medicine.Good Practices in Model-Informed Drug Discovery and Development: Practice, Application, and Documentation Pharmacometrics and the transition to model-based development.Pharmacometrics: a multidisciplinary field to facilitate critical thinking in drug development and translational research settings.The in silico child: using simulation to guide pediatric drug development and manage pediatric pharmacotherapy.A survey of the way pharmacokinetics are reported in published phase I clinical trials, with an emphasis on oncology.Defining a therapeutic window for the novel TGF-β inhibitor LY2157299 monohydrate based on a pharmacokinetic/pharmacodynamic model.Improving productivity with model-based drug development: an enterprise perspective.ASCPT Task Force for advancing pharmacometrics and integration into drug development.Structural models describing placebo treatment effects in schizophrenia and other neuropsychiatric disorders.Impact of pharmacometric analyses on new drug approval and labelling decisions: a review of 198 submissions between 2000 and 2008.The current role of model-based drug development.Model-based clinical drug development in the past, present and future: a commentary.Kidney function assessment and its role in drug development, review and utilization.Drug-drug interaction discovery and demystification using Semantic Web technologies.Clinical Trial Design in Juvenile Idiopathic Arthritis.Advanced Methods for Dose and Regimen Finding During Drug Development: Summary of the EMA/EFPIA Workshop on Dose Finding (London 4-5 December 2014)Optimizing drug development in oncology by clinical trial simulation: Why and how?Role of Quantitative Clinical Pharmacology in Pediatric Approval and Labeling.Clinical pharmacology, creating current and future success in drug development.Quantifying pain relief following administration of a novel formulation of paracetamol (acetaminophen).Pharmacometrics 2020.Model-based drug development survey finds pharmacometrics impacting decision making in the pharmaceutical industry.Pharmacometrics as a discipline is entering the "industrialization" phase: standards, automation, knowledge sharing, and training are critical for future success.Pharmacometric Analyses to Support Early Development Decisions for LY2878735: A Novel Serotonin Norepinephrine Reuptake Inhibitor.Importance of shrinkage in empirical bayes estimates for diagnostics: problems and solutions.Use of a biomarker in exposure-response analysis to support dose selection for fingolimod.Quantification of apixaban's therapeutic utility in prevention of venous thromboembolism: selection of phase III trial dose.Mathematical modeling in immunotherapy of cancer: personalizing clinical trials.A model for glucose, insulin, and beta-cell dynamics in subjects with insulin resistance and patients with type 2 diabetes.Integration of biostatistics and pharmacometrics computing platforms for efficient and reproducible PK/PD analysis: a case study.

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Impact of pharmacometrics on drug approval and labeling decisions: a survey of 42 new drug applications.

http://www.wikidata.org/entity/Q36341645

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B Nhi Beasley

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Brian P Booth

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Chandrahas G Sahajwalla

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J Robert Powell

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Jogarao V S Gobburu

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John Z Duan

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Mehul U Mehta

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Nam Atiqur Rahman

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Patrick J Marroum

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Raman K Baweja

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P2860

Can the pharmaceutical industry reduce attrition rates?

Impact of population pharmacokinetic-pharmacodynamic analyses on the drug development process: experience at Parke-Davis.

Population pharmacokinetics and pharmacodynamics of sotalol in pediatric patients with supraventricular or ventricular tachyarrhythmia.

Renal failure with the use of zoledronic acid.

Intravenous nesiritide vs nitroglycerin for treatment of decompensated congestive heart failure: a randomized controlled trial.

Marrow transplantation for chronic myeloid leukemia: the influence of plasma busulfan levels on the outcome of transplantation.

Intravenous nesiritide, a natriuretic peptide, in the treatment of decompensated congestive heart failure. Nesiritide Study Group.

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10.1208/AAPSJ070351

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1052268149

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